FDA approves Extended Release Tofacitinib (Xeljanz XR) for Rheumatoid Arthritis treatment

On Feb 24, 2016, FDA approved the tofacitinib citrate extended-release (Xeljanz, XR) for the treatment of rheumatoid arthritis (RA). The 11 mg once-daily tablet is indicated for treatment for moderate to severe rheumatoid arthritis for patients who’ve had an inadequate response from methotrexate or intolerance to it.

In 2012, tofacitinib (Xeljanz) was approved by the FDA and became the first oral Janus Kinase (JAK) inhibitor treatment approved for treatment of RA.1

Xeljanz XR 11mg is to be taken once daily and is pharmacokinetically equivalent to the previously approved Xeljanz 5 mg, which is administered twice daily.

In the various clinical trials done for Xeljanz and Xeljanz XR people with RA who were treated with Xeljanz experienced improvement in clinical response and physical functioning compared to people who received placebo.2

It is important to note that Xeljanz and Xeljanz XR can possibly lower the ability of the body to fight infections thus increasing the risk of serious infections like Hepatitis B & C, tuberculosis, cancer, and lymphoma. Therefore, Hepatitis B & C and Tuberculosis should be ruled out for people with RA before beginning treatment. Also, because the immune system’s ability to fight infections is reduced, care should be taken, not to give live vaccines to people with RA on Xeljanz/Xeljanz XR. The various clinical trials also indicated increase in cholesterol and liver enzymes, so people taking this medication should be administered the liver function test regularly.3

The most common adverse reactions that were reported in the clinical trials were upper respiratory tract infections, headache, diarrhea, and inflammation of the nasal passage and the upper part of the pharynx.3

Xeljanz XR is an updated dosing regimen for Xeljanz, which is a drug with established safety and efficacy for the treatment of RA.

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